FDA approves ebola test kit

The test kit, distributed by Roche, is used for the detection of Ebola Zaire Virus in whole blood samples

The test is used for the detection of Ebola Zaire Virus

Singapore: US Food and Drug Administration (FDA) has provided an Emergency Use Authorization (EUA) for German made LightMix Ebola Zaire rRT-PCR Test, distributed by Roche, for use on patients with signs and symptoms of Ebola Zaire virus infection in conjunction with epidemiological risk factors, such as individuals traveling from West Africa.

The test is used for the detection of Ebola Zaire Virus in whole blood samples using the large installed base of Roche's LightCycler 480 or cobas z 480 instruments.

"The LightMix Ebola Zaire test is an easy-to-use molecular diagnostic test providing a solution for healthcare professionals to quickly detect the virus and start patient treatment as early as possible," said Mr Roland Diggelman, COO, Roche Diagnostics Division. "As a leader in diagnostics, Roche is committed to providing testing solutions for the world's most challenging healthcare emergencies. The FDA's granting of this EUA supports our commitment to healthcare professionals working to combat this deadly disease."

Manufactured by Germany based TIB MOLBIOL and distributed by Roche, the LightMix Ebola Zaire rRT-PCR Test is a one-tube duplex assay for the simultaneous, qualitative detection of Ebola Zaire Virus (detected in the West Africa outbreak in 2014) and an endogenous human house-keeping gene used as an internal control. The end-to-end process from sample preparation of whole blood to results can be achieved for 96 results in over 3 hours.